A Trial Comparing Ferumoxytol With Placebo for the Treatment of Iron Deficiency Anemia

• Status: Completed
• Trial end date: 2012-10-22
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate the efficacy and safety of intravenous (IV) ferumoxytol compared with placebo for the treatment of iron deficiency anemia (IDA).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AMAG Pharmaceuticals, Inc.
• Treatments: Ferrosoferric Oxide; Iron

Criteria

Key Inclusion Criteria include:

1. Males and females ≥18 years of age

2. Participants with IDA defined as having:

1. Hemoglobin <10.0 g/deciliter (dL)

2. Transferrin saturation <20%

3. Participants who have a history of unsatisfactory oral iron therapy or in whom oral iron cannot be used

4. Female participants of childbearing potential who are sexually active must be on an effective method of birth control for at least 1 month prior to screening and agree to remain on birth control until completion of participation in the study

Key Exclusion Criteria include:

1. History of allergy to IV iron

2. Allergy to two or more classes of drugs

3. Participants on dialysis or with an estimated glomerular filtration rate <30 mL/minute/1.73 m^2

4. Female participants who are pregnant, intend to become pregnant, are breastfeeding, within 2 weeks postpartum, or have a positive serum/urine pregnancy test

5. Hemoglobin ≤7.0 g/dL

6. Serum ferritin >600 nanograms/mL